Annexes to COM(2018)51 - Health technology assessment

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dossier COM(2018)51 - Health technology assessment.
document COM(2018)51 EN
date December 15, 2021
agreements and contracts resulting from the financing of implementing activities under this proposal will expressly entitle the Commission, including the Anti-Fraud Office (OLAF), and the Court of Auditors, to conduct audits, on-the-spot checks and inspections;

‒    during the evaluation phase of a call for proposals/tender, the proposers and tenderers are checked against the published exclusion criteria based on declarations and the Early Detection and Exclusion System (EDES);

‒    the rules governing the eligibility of costs will be simplified in accordance with the provisions of the Financial Regulation;

‒    regular training on issues related to fraud and irregularities for all staff involved in contract management as well as to auditors and controllers who verify the beneficiaries' declarations on the spot.

Moreover, the Commission will oversee a strict application of the rules on conflicts of interests provided for in the proposal.

3. ESTIMATED FINANCIAL IMPACT OF THE PROPOSAL

As the budgetary consequences of the proposal are expected to take effect from 2023 onwards, the contribution from the EU budget post-2020 will be discussed within the framework of the preparation of the Commission's proposals for the next Multiannual Financial Framework (MFF) and will reflect the outcome of the negotiations on the MFF post-2020.

The proposal is compatible with the current MFF.

(1) Relevant legislation includes Directive 2001/83/EC, Regulation (EC) No 726/2004), Regulation (EU) 536/2014, Regulation (EU) 2017/745 and Regulation (EU) 2017/746.
(2) Note that the need for improved synergies has been recognised by Member States in the HTA Network Reflection Paper "Synergies between regulatory and HTA issues on pharmaceuticals" as well as by EUnetHTA and EMA in their joint "Report on the implementation of the EMA-EUnetHTA three-year work plan 2012-2015".
(3) https://ec.europa.eu/health/technology_assessment/events_en#anchor3
(4) http://ec.europa.eu/smart-regulation/roadmaps/docs/2016_sante_144_health_technology_assessments_en.pdf
(5) Seconded national experts are national civil servants or persons employed in the public sector who are working temporarily for an EU Institution. They remain in the service of that employer throughout the period of secondment and receive a daily allowance from the European Commission in line with the provisions in the Staff Regulation.
(6) OJ C , , p. .
(7) OJ C , , p. .
(8) OJ C 438, 6.12.2014, p. 12.
(9) European Parliament resolution of 2 March 2017 on EU options for improving access to medicines – 2016/2057(INI).
(10) COM(2015) 550 final p. 19.
(11) Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (OJ L 136, 30.4.2004, p. 1).
(12) Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (OJ L 117, 5.5.2017, p. 1).
(13) Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by the Member States of the Commission's exercise of implementing powers (OJ L 55, 28.2.2011, p. 13).
(14) Interinstitutional Agreement between the European Parliament, the Council of the European Union and the European Commission of 13 April 2016 on Better Law-Making (OJ L 123, 12.5.2016, p. 1).
(15) Directive 2011/24/EU of the European Parliament and of the Council of 9 March 2011 on the application of patients’ rights in cross-border healthcare (OJ L 88, 4.4.2011, p. 45).
(16) Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (OJ L 311, 28.11.2001, p. 67).
(17) Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU (OJ L 117, 5.5.2017, p. 176).
(18) Regulation (EU, Euratom) No 966/2012 of the European Parliament and of the Council of 25 October 2012 on the financial rules applicable to the general budget of the Union and repealing Council Regulation (EC, Euratom) No 1605/2002 (OJ L 298, 26.10.2012, p. 1).
(19) As referred to in Article 54(2)(a) or (b) of the Financial Regulation.